1/19-2023- The ARE YOU DENSE ADVOCACY committee continues to recognize the importance of patients receiving their own personal medical information and directs the Food and Drug Administration to ensure that mammography reports and summaries received by patients and their providers include appropriate information about breast density specified by the Secretary, including, at a minimum, the effect of breast density in masking the presence of breast cancer on a mammogram, the qualitative assessment of the provider who interpreted the mammogram, and a reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary. From a prior report (3/28/2019) the Department of Health and Human Services, the FDA announced changes to the MQSA (Mammography Quality Standards Act) to include reporting of dense breast tissue to the patient- by and large, thanks to the Are You Dense Advocacy, Inc. Today, [1]
Joe Cappello / Are You Dense? Foundation
According to a 12/13/2022 press release, Congresswoman Rosa DeLauro (CT-03), Congressman Brian Fitzpatrick (PA-01), and award-winning journalist Katie Couric introduced their legislation, the Find It Early Act. This bill would ensure all health insurance plans cover screening and diagnostic mammograms and breast ultrasounds and MRIs with no cost-sharing. “It means a great deal to me to join Katie Couric, Congressman Fitzpatrick, and all of the breast cancer advocates here to talk about what we must do to detect breast cancer early and save women’s lives,” said Congresswoman Rosa DeLauro. “As we all know, when it comes to surviving cancer, early detection is key – as 99 percent of women who receive an early diagnosis survive it. That is why today I am introducing the Find It Early Act, which would mandate all insurance providers to cover additional screenings including diagnostic mammograms, breast ultrasounds, and breast MRIs, with no cost-sharing.” “At DenseBreast-info we hear from women all the time who find out they have dense breasts and that they would benefit from additional screening, but then discover they have to navigate getting approvals from their insurance providers - and begina frustrating cycle of phone calls, denials, appeals and more phone calls,” said JoAnn Pushkin, Executive Director of DenseBreast-info, Inc. “The Find it Early Act will help ensure that when a woman is told that her mammogram might not be enough – she will not have to struggle to pay for additional imaging, orchoose between household bills and a recommended test, or spread the cost of an MRI over one year, and skip the next year because the cost of the exam has strained her budget.”
“It is my pleasure to give a voice on behalf of many hundreds of dense breast cancer patients who have become advocates across this country to say THANK YOU Congresswoman DeLauro,” said Joseph J. Cappello, Executive Director and Co-Founder of Are You Dense Advocacy, Inc. “We thank you for taking the initiative as a leader in our 18-year battle, by demanding the FDA take action on the new MQSA rule by the end of this month. Your leadership will save many hundreds of lives across the nation.” [4]
Video News Release: Innovations in Early Detection
"Are You Dense?" Foundation Co-founder Joe Cappello joins the medical diagnostic community to promote the "Get Checked Now!" campaign. Dr. Robert Bard from the Bard Cancer Center (NYC) supports supplemental imaging including the 3D Doppler Ultrasound scanner to offer dense breast detection. This video presents some of the latest advancements in ultrasound features to detect tumors through dense breast tissue- reportedly a significant challenge with mammograms.
WHAT'S NEW AT THE MQSA (NATIONAL STATISTICS)
Welcome to MQSA Insights. These pages provide information pertaining to the Food and Drug Administration’s (FDA) Mammography Quality Standards Act’s (MQSA) program. Our ultimate goal is to help facilities improve the quality of mammography by allowing them to see how facilities as an aggregate are doing across the nation as well as through exploring specific mammography topics. Such information is designed to:
inform the public on how mammography facilities are doing overall complying with MQSA standards
highlight other important MQSA statistics and trends
allow facilities to compare how they are performing to the performance of facilities as a whole [2]
Updated from a video feature originally launched on 10/14/2022, Spotlight on America (TND) presented an ongoing report: "A SHOCKING DIAGNOSIS". Suzanne McDonald was 48 years old when she got a routine mammogram in 2007. Like so many women, she received a letter telling her the X-ray was clear, and she breathed a sigh of relief. McDonald threw her letter in the garbage, trusting that it told her all she needed to know. She’d later find out that the mammogram had missed what was happening in her body: late-stage 3C cancer, which had been concealed by extremely dense breast tissue, which McDonald had never heard of.
The image of a tumor in a dense breast (R) is like a polar bear in a snowstorm,” Dr. Robert Bard, a leading radiologist, told us. “It’s white against white, you can’t see it. So we’ve been missing tumors all the time.” Bard, the founder of the Bard Cancer Center, told us the lack of contrast in those crucial images means millions of women could miss their best chance at early detection. “Women with dense breasts are 5 to 7 times more likely to develop a breast tumor,” said Dr. Bard. “So given that you’re already at increased risk by having a high breast density, this is cause for making sure you get screened.”
Special thanks to TND/ Andrea Nejman | National Investigative Producer & Spotlight on America, Inside Your World Investigates
HANDY PATIENT GUIDE TO SCREENING OPTIONS FOR DENSE BREASTS
This patient-friendly guide outlines the benefits and harms of screening options for dense breasts. The two-page guide is based on current scientific and medical research on technology and dense breast tissue. The guide illustrates the approximate cancer detection rate for each exam. Bring this guide with you as you discuss your screening options with your health-care providers based on your risk, dense tissue and preferences. Keep in mind that all studies have limitations. The chart can be printed one page, back to back. (Special thanks to Julie S. Gershon, MD for her expert review). Download Chart in PDF here. [3]
By: Robert L. Bard, MD & Noelle Cutter, PhD | Edited by: Lennard M. Gettz, Ed.D
PROLOGUE
In 2014, Imaging Technology News (ITN) introduced breast cancer survivor-turned-crusader Dr. Nancy Cappello and her story about having dense breast tissue leading to a late-stage cancer. A false negative mammography scan (diagnosed in 2004) concealed a large 2.5 cm suspicious lesion, which was later confirmed to be stage 3c breast cancer. This same cancer had metastasized to 13 lymph nodes. This sparked Dr. Cappello to create the "Are You Dense?" Foundation- an international awareness crusade to better support dense breast diagnostics and initiatives pass legislation to enact laws requiring mammography centers to inform patients about their breast density and the associated cancer risks. Dr. Cappello passed away on Nov 15, 2018, from secondary myelodysplastic syndrome (MDS), a bone marrow cancer that was a complication of her prior aggressive breast cancer treatments. But she ignited a legacy of fighting for improved policies, imaging technologies and advanced research to better address this health crisis that puts the est. 40% of the female population (women with dense breasts) at risk of a false negative reading.
PART 1: USE OF ULTRASOUND IN A 2021 RESEARCH STUDY OF BREAST DENSITY
In an ongoing clinical study co-investigated by Dr. Robert Bard (NYC) and Dr. Noelle Cutter (of Molloy College, Long Island, NY), data is collected from a cohort of women undergoing ultrasound density scans. Inspired by Dr. Cappello’s early surveys of specific demographic groups, this 2021 research explores dense breast predominance in the younger population or those with lower body mass index (including dancers and athletes), both are likely candidates to receive false negative readings on a mammogram.
In addition, breast density is also associated with breast cancer risk in women between ages 40-65, but there is limited evidence of its association with risk of breast cancer among women 18+. This estimated proportion of breast cancers are attributable to breast cancer risk factors commonly documented in clinical practice and used in breast cancer risk prediction models, including BI-RADS breast density and ultrasounds to confirm mammography readings.
Target Objectives
Endurance athletes are to be defined by those who participated in one or more endurance events (long course) in the year or as well as those who are (younger, low BMI cohort) MD and classification of “dense breasts” was heterogeneous and extremely dense as noted by the BIRADS code; (heterogeneously or extremely dense vs scattered fibroglandular densities). Data is collected as odds ratio (OR’s) and 95% confidence intervals included in research outcomes.
Although breast density is a well-established and prevalent breast cancer risk factor, it’s biological connection is not (yet) clearly understood. More research is needed to support the population associated risk proportion in athletic pre-menopausal women. The data gathered from this study reviews a cohort of women undergoing imaging ultrasound scans of pre-menopausal women with dense breasts. Anecdotally, 50 years ago one never saw a 35-year-old with breast cancer. Twenty years ago, it was common to see women in their 20s with cancer. Environmental factors and toxic substance carcinogenic effect may be a byproduct of the research outcome.
Non-invasive Imaging options
1) Diagnostic Ultrasound meets the scanning requirements and is performed in the office setting accurately and rapidly due to the high resolution and low cost of today’s sonographic equipment. Furthermore, advances in the computerization of the imaging, blood flow, and tumor measures of exact volume and vessel density are now less operator dependent- adding ease of use for this or any clinical research requiring the use of ultrasound technology. This provides a reliable and repeatable diagnosis, and a means to follow the individual’s unique pattern of cancer development, progress, and response to treatment.
Recent technological advances also make these procedures available to much broader clinical application, without requiring years of very unique training and clinical experience, for example, with diagnoses of cystic versus solid lesions. Accuracy in assessing breast [1] tumors and metastatic foci has been documented. It must be emphasized that the beginner will find many confusing artifacts and findings should be confirmed with all pertinent imaging modalities.
2) 3D Doppler Ultrasound with Dynamic Contrast Enhanced MRI are the gold standards by which cancers are initially diagnosed or confirmed and serially followed after treatment. The percentage of malignant vessels can be quantified and re-evaluated in the identical tumor volume as serial follow ups to the standard treatments using radiation, surgery, hormones, chemotherapy, cryotherapy, watchful waiting and the non-standard regenerative treatments: ablation using focal laser, focal ultrasound, photodynamic, radiofrequency and microwave technologies. Since vessel mapping is possible, embolic treatments may be considered.
3) 3D Sonography can demonstrate the tumor volume and marginal capsule of locally affected lymph nodes more accurately than the MRI since the resolution is 100 microns at 18 MHz. The exam takes about 10 minutes, and the probes are automated meaning that this is less operator dependent than other sonographic procedures. Vessel density index (VI) imaging is performed on the data set at an independent workstation and comparison made with prior exams if available.
4) 3D Power Doppler indices vary according to the tumor stage, the histologic grade, capsular disruption, and lymph node metastases. Histologic grade has been studied with this technology and the following approximation has proven useful in prostate tumor staging. This quantitative measure of neovascularity was initially applied to prostate cancer. [2] While it does not exactly correlate with histologic Gleason grading since this is a current functional measure while the microscopy is purely anatomical and may not represent current aggressive potential. It’s predictive value of aggression could be studied in the context of breast and other cancers [3,4]
Medical imaging can map the arteries, veins and nerves providing preoperative landmarks reducing postoperative bleeding and avoiding nerve damage. Tumors of low aggressive potential may be treated medically and followed by interval scans or locally reduced by radiation or laser ablation. Biopsies of certain abnormalities may be averted or postponed. (FIG 1)
Fig. 1 - Left black and white coronal ultrasound shows irregular “donut” periphery corresponding to desmoplastic tissue while the right colored elastography demonstrates the fibrotic elements creating the “crater” interior
Part 2: TRACKING BREAST CANCERS AND TUMORS
High tumor vessel density correlates with greater aggression. Axillary and mediastinal imaging can document lymphadenopathy. Abdominal scans simultaneously performed may detect ascites and metastases to the liver, periaortic nodes and pelvic organs. Response to neoadjuvant chemotherapy may be assessed MRI, CT, mammography, PET/CT and ultrasound. The new technology of ultrasound elastography, assessing tumor stiffness, predicts response to treatment accurately and may indicate better therapeutic strategies on a timelier basis. [5] Residual cancer burden scoring could provide better treatment options since the treatment response for evaluation of neoadjuvant chemotherapy needs a more comprehensive and authoritative standard than is currently available.
Lymph Node Disease
Lymph node assessment is possible at the same time. Under sonographic guidance, biopsies may be obtained. Sonographic criteria for malignancy are published elsewhere. Image guidance of enlarged node can distinguish between active tumor and necrotic areas diminishing necessity of repeated aspirations for indeterminate findings. (Fig 2) Pathologic assessment of a large postoperative specimen may be facilitated by high frequency scanning to re-localize the suspect region for targeted study that has been removed from its previous anatomic position. [6] Elastography is useful in targeting sub-centimeter foci in large nodal masses
Fig. 2 - Vessel mapping preoperative
Part 3: IMAGE GUIDED BIOPSY AND TREATMENT
New computer programs use nanotechnology and cybernetic modalities for accurate image guided biopsy and treatment options. Lesions as small as 3 mm have been successfully imaged at frequencies above 14 MHz. Employing 3D sonography with Doppler, the physician manually targets the area of highest tumor neovascularity. This is critical since only part of a mass may be cancerous and missed on non targeted punch biopsies. The marriage with fusion of MRI with ultrasound permits image guided biopsies that spare the adjacent vascular channels. The same technology allows customized ultrasound or MRI guided biopsies to be performed under local anesthesia. Immediate cytologic confirmation of tumor cells permits the withdrawal of the biopsy needle and insertion of a LASER fiber or cryogenic probe immediately treating the proven tumor. MRI thermocoupled sensors prevent overheating of the adjacent nerves and sensitive tissues. Following ablation, the zone of destruction is confirmed with Doppler, contrast ultrasound or DCE-MRI. Inflammatory lesions that are deeply seated may be approached by robotic image guided subdermal injections or targeted biopsies if necessary. This outpatient procedure allows the patient to return to work immediately. RF thermoprobes with temperature auto cutoffs prevent thermal skin damage.[7] Similar user friendly and cost-effective modalities may replace other therapies in the near future. At the 2016 AMERICAN SOCIETY OF LASERS IN MEDICINE meeting in Boston, cutaneous melanoma with in-transit metastases was successively treated by laser technologies [8] MRI Fusion Biopsies with CT and/or ultrasound are routine adding further to the accuracy of image guided biopsies and focal treatment procedures. [9]
Advances in ultrasound elastography progressed from simple strain imaging to shear wave sonography to 3D coronal shear wave elastography where the plane of the image corresponds to the surgical field as the tumor is dissected in the most superficial plane. The tumor desmoplasia in the coronal plane creates a sawtooth irregular border with a central echo pattern simulating a “donut” and is termed the “crater” sign in this increasingly popular imaging paradigm. Elastography is used worldwide primarily in the diagnostic workup of breast, thyroid and prostate tumors and has reduced the number of biopsies on false positive findings from mammography, b-mode ultrasound and MRI.[10]
Fig. 3 - Mixed solid/necrotic axillary lymph node-vessel density allows targeting of active disease
References
1.Bard R. Vascular imaging of cancer in the dense breast. 60th Journees Francaises de Radiologie 2012, Paris
3.Cruwys, Cheryl, and JoAnn Pushkin. “Breast density and impacts on health.” ecancermedicalscience 11 (2017).
4.Nazari, Shayan Shaghayeq, and Pinku Mukherjee. “An overview of mammographic density and its association with breast cancer.” Breast cancer 25.3 (2018): 259-267.
5.Boyd, Norman F., et al. “Mammographic density: a heritable risk factor for breast cancer.” Cancer epidemiology. Humana Press, 2009. 343-360.
6.Burton, Anya, et al. “Mammographic density and ageing: A collaborative pooled analysis of cross-sectional data from 22 countries worldwide.” PLoS medicine 14.6 (2017): e1002335.
7.Azam, Shadi, et al. “Determinants of mammographic density change.” JNCI Cancer Spectrum 3.1 (2019): pkz004.
8.Boyd, Norman F., et al. “Body size, mammographic density, and breast cancer risk.” Cancer Epidemiology and Prevention Biomarkers 15.11 (2006): 2086-2092.
9.Bard R. Image guided cancer treatment. Advances in Medical and Surgical Dermatology, 15th Annual Mt Sinai Winter Symposium New York 2015.
10.Merce L, Alcazar J, Lopez C et al. Clinical usefulness of 3-dimensional sonography and power Doppler angiography for diagnosis of endometrial carcinoma. J Ultrasound Med 2007; 26:1279-1289.
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Research overview: MAMMOGRAPHIC DENSITY, PHYSICAL ACTIVITY AND BREAST CANCER
Written by: Dr. Noelle Cutter / Sept. 12, 2021 Edited by: the publishing team @ NYCRANEWS.com
Mammography, as the primary screening modality, has facilitated a substantial decrease in breast cancer-related mortality in the general population. However, the sensitivity of mammography for breast cancer detection is decreased in women with higher breast densities, which is an independent risk factor for breast cancer. With increasing public awareness of the implications of a high breast density, there is an increasing demand for supplemental screening in these patients. Yet, improvements in breast cancer detection with supplemental screening methods come at the expense of increased false-positives, recall rates, patient anxiety, and costs. Therefore, breast cancer screening practice must change from a general one-size-fits-all approach to a more personalized, risk-based one that is tailored to the individual woman's risk, personal beliefs, and preferences, while accounting for cost, potential harm, and benefits.
FACTOIDS & FIGURES- The Inspiration behind our research initiative [1]:
▪ Breast cancer is the second most common cancer among women in the United States and about 1 in 8 U.S. women (about 13%) will develop invasive breast cancer over the course of her lifetime.
▪ In 2021, it is estimated that over 280,000 new cases of invasive breast cancer will be diagnosed in women in the U.S.,
▪ Over 40,000 women in the U.S. are expected to die in 2021 from breast cancer. Unfortunately, death rates have been steady in women under 50 since 2007, despite advancements in treatment options.
▪ For women in the U.S., breast cancer death rates are higher than those for any other cancer, besides lung cancer.
▪ As of January 2021, there are more than 3.8 million women with a history of breast cancer in the U.S. This includes women currently being treated and women who have finished treatment.
▪ Breast cancer is the most commonly diagnosed cancer among American women. In 2021, it's estimated that about 30% of newly diagnosed cancers in women will be breast cancers.
▪ Breast cancer became the most common cancer globally as of 2021, accounting for 12% of all new annual cancer cases worldwide, according to the World Health Organization.
▪ A woman’s risk of breast cancer nearly doubles if she has a first-degree relative (mother, sister, daughter) who has been diagnosed with breast cancer.
▪ About 5-10% of breast cancers can be linked to known gene mutations inherited from one’s mother or father. Mutations in the BRCA1 and BRCA2genes are the most common. On average, women with a BRCA1 mutation have up to a 72% lifetime risk of developing breast cancer. For women with a BRCA2 mutation, the risk is 69%. Breast cancer that is positive for the BRCA1 or BRCA2 mutations tends to develop more often in younger women.
▪ About 85% of breast cancers occur in women who have no family history of breast cancer.
The most significant risk factors for breast cancer are sex (being a woman) and age. But recent research is beginning to clarify additional risk factors associate with BC
PHYSICAL ACTIVITY Physical activity is considered a significant modifiable factor in breast cancer risk, and since exercise reduces fatty tissue and BMI, it has been thought to increase breast density. However, studies into the relationship between physical activity and breast density have been inconclusive. Other factors such as alteration in metabolism of endogenous hormones, are suggested to influence mammographic density (MD) as well. Therefore, it is evident that the links between physical activity and breast cancer risk need to be clarified.
BREAST TISSUE DENSITY Breast density levels refer to the appearance of the breast tissue on a mammogram. Breast density is part of the supportive or connective tissue that makes up the breast tissue. As you can see in this image, breast tissue is white to gray and transparent against a dark background. Denser breast tissue appears more white whereas fatty/non-dense tissue appears grapy and transparent.
Levels of density are described using a results reporting system called Breast Imaging Reporting and Data System (BI-RADS). The levels of density are often recorded in your mammogram report using letters. The levels of density are:
A: Almost entirely fatty indicates that the breasts are almost entirely composed of fat. About 1 in 10 women has this result.
B: Scattered areas of fibroglandular density indicates there are some scattered areas of density, but the majority of the breast tissue is non-dense. About 4 in 10 women have this result.
C: Heterogeneously dense indicates that there are some areas of non-dense tissue, but that the majority of the breast tissue is dense. About 4 in 10 women have this result.
D: Extremely dense indicates that nearly all of the breast tissue is dense. About 1 in 10 women has this result.
In general, women with breasts that are classified as heterogeneously dense or extremely dense are considered to have dense breasts. Almost half of women undergoing mammograms have dense breasts.
FATTY TISSUE vs. DENSE TISSUE A close up here shows the difference in imaging for a breast tumor on non-dense vs dense breast tissue using a mammogram. Breast density has been widely considered a strong risk factor for breast cancer, with statistics suggesting as much as a six times higher likelihood of the disease in breasts, compared with those with a less dense breast tissue. Not only does dense breast tissue make it harder for a mammogram to pick up small tumors, but dense breasts themselves have been associated with a higher chance of cellular abnormality.
WHY IT MATTERS? Women who have dense breast tissue have a higher risk of breast cancer compared to women with less dense breast tissue. It’s unclear at this time why dense breast tissue is linked to a higher lifetime risk of breast cancer. Understanding that link is extremely important.
Dense breast tissue also makes it harder for radiologists to see cancer. On mammograms, dense breast tissue looks white. Breast masses or tumors also look white, so the dense tissue can hide tumors. But fatty tissue looks almost black. On a black background it’s easier to see a tumor that looks white. So, mammograms can be less accurate in women with dense breasts.
One of the challenges in promoting the widespread utility of breast cancer risk prediction models has been the assertion that most women with a diagnosis of breast cancer have no established clinical breast cancer risk factors or are not considered to be high risk. [1][2] Although it is impossible to determine the cause of breast cancer in any individual case [3] easily assessed risk factors that explain a substantial proportion of incident breast cancers can be used to stratify breast cancer risk for targeted screening [4] and primary prevention [5] and improve public health interventions to reduce breast cancer risk.
Recent research has suggested that for women with dense breasts, a screening strategy that also takes into account a woman’s risk factors and protective factors may be the best predictor of whether a woman will develop breast cancer after a normal mammogram and before her next scheduled mammogram.
MAMMOGRAPHIC DENSITY Breasts contain glandular, connective, and fat tissue. Breast density is a term that describes the relative amount of these different types of breast tissue as seen on a mammogram. Dense breasts have relatively high amounts of glandular tissue and fibrous connective tissue and relatively low amounts of fatty breast tissue.
HOW COMMON ARE DENSE BREASTS? Nearly half of all women age 40 and older who get mammograms are found to have dense breasts. Breast density is often inherited, but other factors can influence it. Factors associated with lower breast density include increasing age, having children, and using tamoxifen. Factors associated with higher breast density include using postmenopausal hormone replacement therapy and having a low body mass index.
Women with dense breasts have a higher risk of breast cancer than women with fatty breasts, and the risk increases with increasing breast density. This increased risk is separate from the effect of dense breasts on the ability to read a mammogram. MD one of the strongest risk factors. And because individuals with denser breasts tend to develop more serious types of breast cancer, understanding the connection is important.
ATHLETES A common question that invariably comes up when discussing breast density relates to breast density in athletes. As an athlete myself who has dense breasts, I was struck by the number of individuals in my athletic community who also have dense breasts. A shocking trend was seen in the overwhelming amount of young women with dense breasts who subsequently had received false negative mammogram reports.
What we do know is that your breast tissue tends to become less dense as you age, though some women may have dense breast tissue at any age. Women with less body fat are more likely to have more dense breast tissue compared with women who are obese. From observation (thus far), athletic women are also more likely to have dense breast tissue. One of the main goals of our study is to really try to understand the biological connection of breast density in athletes as well as run a retrospective study on how common this trend is.
RESEARCH OBJECTIVES It's not clear why some women have a lot of dense breast tissue and others do not. You may be more likely to have dense breasts if you:
▪ ARE YOUNGER; your breast tissue tends to become less dense as you age, though some women may have dense breast tissue at any age.
▪ HAVE LOWER BMI (body mass index); women with less body fat are more likely to have more dense breast tissue compared with women who are obese.
Breast density is shown to be associated with breast cancer risk in women aged 40 to 65 years, but there is limited evidence thus far of its association with risk of breast cancer among women 18+. Furthermore, a high proportion of women with low BMI present with dense breasts, making them likely candidates to receive false negative readings on a mammogram. We aimed to estimate the proportion of breast cancers attributable to breast cancer risk factors commonly documented in clinical practice and used in breast cancer risk prediction models, including BI-RADS breast density and ultrasounds to confirm mammography readings. Our data will be collected from a cohort of women undergoing ultrasound density scans at the Bard Cancer Center (NYC).
Although breast density is a well-established, strong, and prevalent breast cancer risk factor it’s biological connection is not clearly understood. More research is needed to support the population associated risk proportion in athletic pre-menoposal women. Our data will start with a cohort of women undergoing imaging ultrasounds at the Bard Cancer Diagnostic Center. Our population will include pre-menoposal women with dense breasts.
METHODS Endurance athletes are defined those who participated in one or more endurance events (long course) in the year or as well as those who are (younger, low BMI cohort). MD and classification of “dense breasts” was heterogeneous and extremely dense as noted by the BI_RADS code; (heterogeneously or extremely dense vs scattered fibroglandular densities). Data will be collected as odds ratio (OR’s) and 95% confidence intervals included in our outcomes
Cross-sectional Analysis
1000+ pre-menopausal women aged 18+
Collect information on height, weight, BMI and history of disease
Physical activity assessment
MD measurement performed by radiologist and confirmed by ultrasound
Logistic regression used to estimate the association of MD within participation in physical activity
JAMA STUDY: A recent report in Journal of the American Medical Association found that first-degree family history of breast cancer dense breasts were associated with an increased population associated risk proportion of breast cancer. Among premenopausal women, the largest individual population associated risk proportion was for breast density, with 28.9% (95% CI, 25.3%-32.5%) of breast cancers potentially removed by reducing breast density from BI-RADS heterogeneously or extremely dense breasts to scattered fibroglandular densities. The population associated risk proportion for breast density increased to 65.5% (95% CI, 60.4%-70.6%) if all premenopausal women reduced their breast density to the lowest category of almost entirely fat tissue.
SUMMARY/ WRAP-UP Given that greater breast density as categorized by the BI-RADS remains a factor associated with breast cancer for all ages of women, information about breast density together with life expectancy may benefit clinical decision-making regarding screening. In March 2019, the US Food and Drug Administration recommended changes to the Mammography Quality Standards Act to make it mandatory to report breast density information to both patients and their physicians. However, how women and their physicians should use this information to inform screening recommendations is unclear. Very dense breasts may increase the risk that cancer won't be detected on a mammogram.
What is clear is that additional research is needed to elucidate the mechanisms underlying the observed associations between breast density and risk of breast cancer. As newer and more advanced breast density assessment techniques are developed, evaluation of the diffusion of such innovations with an aim of developing individualized screening strategies will be important, particularly among athletic women, for whom dense breast are more likely seen.
EPILOGUE
Dr. Noelle Cutter is a professor of biology, ironman finisher, and advocate for dense breast screening. United with an expanding research team dedicated to collecting data on women with dense breasts and screening options for these patients, her initiative aims to investigate and gather conclusive information about dense breasts in specific groups- including age, body mass index, and amount of physical activity and the underlying diagnostics of breast cancer tumors. This research program is under a partnership with Molloy College and Dr. Robert Bard, expert diagnostic cancer imaging specialist in NYC and other colleagues from the NY Cancer Resource Alliance.
With your support, we are able to implement this screening program for women's health as well as help fund this clinical research. Our work will advance technology, change legislation and most importantly save lives through awareness.
On July 27-29, Bard Diagnostic Imaging is offering a comprehensive DENSE BREAST SCREENING DAY, employing an array of imaging advancements dedicated to the visibility of dense breast tissue and cancer early detection. This special program is dedicated to supporting dense breasted patients by first identifying one's actual breast density (through a density assessment scan) to establish a base line for the full diagnostic study (est. 15-20 minutes per patient).
Dr. Bard has formulated a comprehensive early detection program specific for dense breasted women. This includes the latest technologies in breast ultrasound, scanning. "We need screening technology for dense breasts because the mammography misses too many cancers in dense breast. So patients are happy to know that this technology is here. If there is a problem, you focus in on it in three dimensions, you find out where it is, and then you, uh, address it with a biopsy or an MRI or a specialized ultrasound." For decades. The ultrasound has advanced greatly in accuracy and reliability to scan quickly. In real time, patients are attracted to its safety aspect, eliminating concerns for radiation and other physical after effects.
2) Cruwys, Cheryl, and JoAnn Pushkin. “Breast density and impacts on health.” ecancermedicalscience 11 (2017).
3) Nazari, Shayan Shaghayeq, and Pinku Mukherjee. “An overview of mammographic density and its association with breast cancer.” Breast cancer 25.3 (2018): 259-267.
4) Boyd, Norman F., et al. “Mammographic density: a heritable risk factor for breast cancer.” Cancer epidemiology. Humana Press, 2009. 343-360.
5) Burton, Anya, et al. “Mammographic density and ageing: A collaborative pooled analysis of cross-sectional data from 22 countries worldwide.” PLoS medicine 14.6 (2017): e1002335.
6) Azam, Shadi, et al. “Determinants of mammographic density change.” JNCI Cancer Spectrum 3.1 (2019): pkz004.
7) Boyd, Norman F., et al. “Body size, mammographic density, and breast cancer risk.” Cancer Epidemiology and Prevention Biomarkers 15.11 (2006): 2086-2092.
8) Masala, Giovanna, et al. “Can Dietary and Physical Activity Modifications Reduce Breast Density in Postmenopausal Women? The DAMA Study, a Randomized Intervention Trial in Italy.” Cancer Epidemiology and Prevention Biomarkers 28.1 (2019): 41-50.
9) Wyshak, Grace, and Rose E. Frisch. “Breast cancer among former college athletes compared to non-athletes: a 15-year follow-up.” British journal of cancer 82.3 (2000): 726.
10) McCormack VA, dos Santos Silva I. Breast density and parenchymal patterns as markers of breast cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2006;15(6):1159-1169.
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RUNNING THE TORCH OF A DENSE BREAST CANCER CHAMPION
Dr. Noelle Cutter drives the spirit of Dr. Nancy Cappello's mission for early cancer detection for women with dense breasts alongside Dr. Robert Bard's dense breast screening pilot program (8/27-29) - and the global pursuit to expand current screening standards.
A mammogram shows how dense your breasts are. When you get the results of your mammogram, you may also be told if your breasts have low or high density. Women with dense breasts have a higher risk of getting breast cancer.
PARTS OF THE BREAST
A woman’s breast has three kinds of tissue: FIBROUS TISSUE holds the breast tissue in place. GLANDULAR TISSUE is the part of the breast that makes milk, called the lobes, and the tubes that carry milk to the nipple, called ducts. Together, fibrous and glandular tissue are called fibroglandular tissue. FATTY TISSUE fills the space between the fibrous tissue, lobes, and ducts. It gives the breasts their size and shape.
BREAST CANCER RISK: Women with dense breasts have a higher chance of getting breast cancer. The more dense your breasts are, the higher your risk. Scientists don’t know for sure why this is true. Breast cancer patients who have dense breasts are not more likely to die from breast cancer than patients with non-dense (fatty) breasts.
7/8/2021- A wave of recognized medical sites, journals and reports are now indicating that dense breast tissue increases the risk of developing breast cancer and often masks a tumor from being seen on the mammogram since dense tissue is white and cancerous tissue is also white. Mammograms are the standard screening test for breast cancer, however, in the 21st Century, ultrasound non invasive imaging is the preferred exam for dense “lumpy” mammary disease.
The 1st World Conference of Breast Ultrasound in Philadelphia (1979) recognized ultrasound superiority in dense breast diagnostics but the density level was never quantified until recently. Mammography assessment of breast density is graded into four categories. Mammographers readily admit that these levels are subjective at best and technical factors such as mammary tissue compression and x-ray voltage/amperage dramatically influence the darkness or whiteness of the image.
URGENCY IN THE EVOLUTION OF TECHNOLOGY & IMAGING STRATEGIES FOR DENSE BREASTS
Written by: Dr. Robert L. Bard
Decades since the advent of breast scanning technology, innovations in non-invasive diagnostic imaging provide new options in the field of early detection. These technologies directly align with breast density screening (and are part of the Bard Breast Density Diagnostic Program) include:
• Doppler blood flow
• Contrast enhanced ultrasound vascularity
• 3D Vessel Density Histogram
• 4D Volumetric Density Histogram
• Strain and shear wave tissue Elastography
• 3T MRI
• Optical Computed Tomography (OCT) for nipple lesions
• Reflectance Confocal Microscopy (RCM) for dermal invasion
• Hybrid Mammo Imaging Fusion
•Thermo-sensor
•Trans Illumination
•Near Infrared Specroscopy
Hybrid imaging refers to combining diagnostic modalities to assess disease and monitor therapy. A useful combination of options is the tumor vessel flow density to assess aggression and treatment progress. Similarly, tissue elastography is useful for border detection of malignant masses.
Drastic
changes in the incidence, diagnosis and treatment of breast cancer and benign
breast disease highlight a singular need for an up to date source on the early
detection and proper therapy of breast tumors.The age of occurrence of breast cancer, formerly only a problem of older
women, is now at a median age of 45 years.This means that women in their twenties are developing breast
cancer.Although risk factors have been
identified, the jeopardy to life is unchanged.The increasing use of estrogen for osteoporosis and other female disorders
may elevate the risk of breast cancer.One out of every eight women will develop breast cancer.Fortunately, the vast majority of tumors in
younger women are benign and can be diagnosed by simple, safe non surgical
tests.Jewish women, prone to breast
cancer, are further plagued by the concomitant presence of fibrocystic breasts
that are lumpy and mask a growing breast cancer.
The incidence of miss by mammography
increases markedly in younger patients and those with "mastitis" or
"cystic" breasts.A paper from
the University of Indiana Medical Center on the mammographic diagnosis of
fibroadenomas (benign tumor of young women) demonstrated that in 35 surgically
proven biopsies, the mammogram missed every mass. A non x ray exam, called the
sonogram, was able to diagnose every tumor in this study. Another non-x ray
test, called Doppler ultrasound, according to DIAGNOSTIC IMAGING (1988) and
CLINICAL RADIOLOGY (1990) may detect breast tumors not seen by all other tests.
Light scanning is another procedure that uses computers and fiberoptics to
visualize tumors.
The
latest text book on Breast Disease, BREAST ULTRASOUND by Thomas Stavros (Lippincott,
2002) mentioned that most abnormalities of the breast may be better
characterized or even detected only by diagnostic ultrasound procedures. JAMA
(May 1993) noted mammography readings were highly variable with many false
positives. Moreover, one expert missed 67% of cancers on high quality
mammograms.Indeed, top mammographers disagreed clinically in 1/3 of
readings.
Since
cancers may lie dormant for up to ten years and that mammography is less
accurate in younger women, one realizes that sonography becomes necessary for a
complete workup in the detection of invasive. Mayo Clinic computer program
shows sonograms capable of 99% accuracy. The latest malpractice newsletters
warn physicians that they are liable if they miss a breast cancer because they
have not performed a sonogram. In fact, the PIAA Data Sharing Report shows that
the patient found the tumor in 69% of cases, mammography missed or was
equivocal in 49% and the median age of breast cancer was 43 years of age. False
negatives were highest in the under age 40 group comprising 40% of claims.
BREAST
IMPLANTS
Every
year over 150,000 women have breast implants. Recent press has pointed to the
problem of breast cancer development in the augmented breast and the inability
of mammography to see it.
Mammography
has also long been used as the primary diagnostic imaging study for
complications of breast augmentation in the over one million women who
currently have breast implants. However, lack of accuracy of both mammographic
information and clinical interpretation have necessitated the application of
the non x ray imaging modalities of light scanning, sonography and duplex
Doppler ultrasound.
Every
plastic surgeon has received a radiologist's mammogram report on a patient in
whom a long standing implant has been removed for various complications that
referred to the ovoid shaped density as a "prosthesis in
position."Radiographically, the
hard capsule that forms after a year cannot be differentiated from certain
implant devices. Also, a leakage of silicone gel that is restricted to the
fibrous capsule is not separately distinguishable. Thus, x rays are inadequate
for the diagnosis of implant rupture except where the silicone has extruded
physically through the capsule. Even then, the routine views may not
demonstrate leakage that is close to the surface of the capsule so that it will
only be identified by a tangential x ray beam. An irregular outline of an
implant may be positional, caused by adjacent breast pathology, resultant of
fibrous septation or actually due to implant rupture.
A sonogram identifies an implant much the same as a cyst. Thus the size, shape, position, peripheral
envelope, wall contour and internal echo pattern are readily demonstrable.
Rupture of an implant, whether from structural failure, interoperative damage,
penetrating trauma or blunt trauma such as closed capsulotomy, is quickly and
accurately diagnosed by routine high frequency sonography.
Sonography
is also important in breast cancer diagnosis since the implant masks most of
the breast from the x ray. Dr. Levine, in the 1990 article: DEFINITIVE
DIAGNOSIS OF BREAST IMPLANT RUPTURE BY ULTRASONOGRAPHY in "Plastic and
Reconstructive Surgery" states that sonography is the best imaging
modality for the augmented breast.
Perhaps
more interesting are the roles of light scanning and duplex Doppler imaging in
the diagnosis of the cause of the implant rupture. Spontaneous failure of the
envelope will be accompanied by fluid extravasation. If recent and localized,
light scanning and Doppler flows will be unremarkable. A long standing leakage
may become secondarily infected, thus producing unilateral light absorption.
Similarly, trauma, intraoperative or external, may be associated with bleeding
which will also absorb light rays. Thus, a normal light scan exam in
transillumination suggests the probability of structure failure of the implant.
Duplex Doppler may shows linear fluid filled structures to be adjacent arteries
or veins. Additionally, this procedure may detect cancers adjacent to the
implant.
The
treatment of breast disease has also changed from the days of deforming radical
mastectomies.Simple removal of the
tumor followed by mastectomy, chemotherapy and radiation therapy are now
available.Post mastectomy
reconstructive surgery will often restore a woman to her former natural
shape.In England
and Australia,
where breast ultrasound and Doppler analysis are routinely used, exploratory
surgery has decreased 90%.The American
Cancer Society stresses self examination and mammography.Unfortunately, the survival rate of breast
cancer has not changed in the past 25 years.Clearly, other diagnostic exams are needed, since the cure rate is
related to the early detection of the disease. Alarmingly, despite many years
of ongoing, improved and massive breast cancer screening, the US National
Center for Health Statistics now sates that the incidence of number of cases of
this disease is actually increasing.
Many
women are overwhelmed with the variety of medical tests and their safety.
Recent articles in the NY Times stated that the female patient is
psychologically ill equipped to deal with the emotional trauma of breast cancer
at the time of diagnosis. These reports suggest that women be well informed
prior to the discovery of a tumor, so that they may make a better informed
decision.The book addresses the
specific type of exam for both early detection of breast disease as well as the
optimal test for specific disorders for each individual woman in an orderly,
sequential and safe format.The pro's
and con's of treatment protocols are also formatted.The author, a radiologist specializing in new
methods of breast imaging, has been lecturing for the Ultrasonic Institute on
new methods of breast cancer detection since 1973 at medical centers around the
nation and at international conferences and mentions in this book all types of
exams and therapies.The reader chooses
for herself what modality may be most suitable.Methods used in Europe, for example,
find acceptance in American medicine twenty or thirty years later.Some medical regimens may be generally
unsuitable for patients, yet may be ideal or the only possibility for an
individual woman.Diagrams of the
various exams are available for better appreciation of the visually oriented
test.As a ready reference format, each
chapter is preceded by a one page summary for quick review.The overall aim of the work is to be a health
"bible" for breast disorders for the 1990's woman.
It is obvious that too few women are getting
the message about the importance of early breast cancer detection since they
fear that it will be too late or the therapy will be too deforming.The purpose of the book is to show that CHANCES
ARE ITS BENIGN, AND, PROPER TREATMENT CAN SAVE YOUR LIFE AND NOT
DISFIGURE.The work reaches out to the
reader to reassure her with dramatic evidence that taking control of her
breasts' health in a planned, stepwise manner can mean the difference between
the words:"The scan shows it's a
cyst.Don't worry" and the chilling
sentence, "we could have helped you if you come in earlier."Women walk out of my office, knowing that
their lump is benign and that their fears are nothing, looking ten years younger.
Women with cancer can be helped because of
the simple techniques used when tumors are small.Even men develop breast cancer at a rate approximately
1% that of women. Most women do need to know that CHANCES ARE ITS BENIGN.Since the age range of breast cancer is now
from the teens to the hundred's, women of all ages need to become actively
involved in managing their health just as they do their finances. Since all
women are at risk of breast cancer, all families must know the facts and the
choices involved. Jewish women, successful women, women on hormones, women with
breast implants and the growing number of health conscious people of all ages
will want to know thee available regimens so they have the data necessary to
knowledgeably take charge of the their own lives.
REVIEW
OF CURRENT MEDICAL LITERATURE
Fleisher's
DIAGNOSTIC SONOGRAPHY (Saunders 1989) states that a sonogram is the best method
for diagnosing benign disorders and that a mammogram is the better tool for
diagnosing malignant diseases. He quotes the sensitivity of sonograms in cancer
detection at 69% as compared to the mammographic detection rate at 74%. The
author's own series using a hand held real time unit (same as Dr. Bard's) shows
an accuracy in detecting palpable lesions of 85% for sonograms and 70% for
mammograms. Both modalities yield a rate of 89% and he recommends both tests be
used in combination.
Hagen-Ansert's
TEXTBOOK OF DIAGNOSTIC ULTRASOUND (Mosby 1989) states sonogram is clinically
useful in a) dense breastsb) younger
patientsc) uncertain mammographic
findingsd) pregnant patientse) implantsf) differentiation of cystic from solid in a known mass
Kopan's
BREAST IMAGING (Lipincott 1989) states that sonography should not be used for
cancer screening. However, he quotes studies by Sickle's, Cole, and Egan
showing respectively that sonogram detects cancers at the following rates: 58%,
78% and 79% in the general population
Britton's
article in CLINICAL RADIOLOGY (1990) demonstrates duplex doppler having a sensitivity
of 91% and specificity of 89%.
Levin's
paper in PLASTIC AND RECONSTRUCTIVE SURGERY (1991) mentions that mammography is
unreliable in the post augmented breast and that ultrasonography is the test of
choice for evaluation of breast prostheses.
Dixon's paper in BRITISH J SURGERY (1992) showed 78%
sensitivity and 100% specificity for carcinoma using duplex Doppler.
Adler’s
abstract in ULTRASOUND MED BIOL (1990) has 82% detection rate of malignant
neovascularity with duplex Doppler.
Scatarige's
note in THORACIC RADIOLOGY (1989) shows high accuracy of staging internal
mammary lymphadenopathy.
Jones
review in CLINICAL ONCOLOGY (1990) had sonograms picking up axillary nodes
missed by other methods in 27% of cases.
Levin's
paper in PLASTIC AND RECONSTRUCTIVE SURGERY (1991) mentions that mammography is
unreliable in the post augmented breast and that ultrasonography is the test of
choice for evaluation of breast prostheses.
Parker's
lecture at the NYU BREAST CANCER UPDATE (1993) showed sonography's ability to
detect unsuspected cancers as small as 0.4 cm and determine whether the
associated lymphadenopathy was malignant or benign. Mendellson's 1992 talk at
DOWNSTATE MEDICAL CONFERENCE showed sonograms to be able to discover occult
lesions.
Barth's
1993 study showing sonograms detected more than twice as much multicentric
breast cancer than mammography.
Stavro's
1997 paper shows accuracy in detecting benign disease solely by ultrasound at
99.7 %.
Bard's
paper in 1993 NY STATE JOURNAL OF MEDICINE revealing mammographic misses in
breast implant imaging.
Bard's
1994 lecture at the MAYO CLINIC highlighted the accuracy of multimodality
imaging.
Bard's
1996 FEMALE PATIENT paper showed 99% accuracy in benign disease diagnosis
CONCLUSION
As
breast cancer strikes younger women due to lowering of the median age of
occurrence, screening procedures become imperative.
Although
mammography is the only generally accepted screening modality, it is clearly of
limited use in younger patients or those with fibrocystic breasts.The inaccuracy of sonograms is true if one
considers the total population to be screened will predominate in older age
groups. Kopan's, in his textbook, admits that he chooses to do sonograms on
women under 28 because of anecdotal evidence that it works best. Dr. Bard's
suggestion is that sonograms be the screening procedure of choice in younger
women and those with fibrocystic breasts. Mammography should remain the gold
standard in women over 40 or those with fatty breasts of any age. The
combination of light scanning, Doppler ultrasound and standard sonograms of the
breast often mean the difference between delayed diagnosis and immediate
surgery. Multimodality imaging, the emphasis of this book, offers the patient
the difference between weeks of worry for the mammogram to be repeated for
"interval change" or for an immediate answer that the problem is
benign.
COMPETITION
Aside
from a few books on cancer and women's diseases, there are no non-medical books
on the spectrum of new tests and therapies for breast disease.Given the epidemic proportions of breast
cancer, the time is right for a new and comprehensive manual for today's
concerned and aware women.
Books
on personal health include THE DOCTOR BOOK, by Wesley Smith (Price Stern Sloan,
L.A. 1987) which has one paragraph on breast exam by a physician and one
paragraph on mammography.
The
NY TIMES GUIDE TO PERSONAL HEALTH by Jane Brody (Avon,
1982) has 7 pages on breast cancer with 2 paragraphs on diagnostic tests.
HORMONES,
by Lois Jovanovic, MD (Fawcett, 1987) includes 26 pages on breast disease,
mentioning the fact that 90% of breast cancers are detected by women
themselves, leaving the reader to wonder at the value of the
"gold-standard" examsof
mammography and 2 pages on hormone therapy for breast cancer.
CHOICES,
by Marion Morra and Eve Potts (Avon 1987) also titled:Realistic alternatives in cancer therapy, has
one chapter on breast cancer, with 6 pages on mammography, one paragraph each
on ultrasound, computed tomography, transillumination and thermography.There are 16 pages on surgery and
radiotherapy and 29 pages on post operative care.
Lauersen's
IT'S YOUR BODY (Berkely 1983) on p.418 states that sonograms will be effective
in the future. Indeed, Dr. Lauersen routinely now performs sonography on his
patients semiannually or more often in his private office.
Gross's
WOMEN TALK ABOUT BREAST SURGERY (Harper 1991) has 2 pages mentioning a
particular cancer was missed by mammogram and sonogram.
Levy's
YOUR BREASTS (Noonday 1990) says one 1 page that benign cysts that are not
palpable or show on x ray may be imaged with sonograms.
Thompson's
EVERY WOMAN'S HEALTH (Prentice Hall 1990) says on one page that sonograms are
useful in cyst detection.
Better
Homes and Garden's FAMILY MEDICAL GUIDE (1989) mentions that sonogram
is useful if mammography is unclear.
Harvard's
YOUR GOOD HEALTH (HARVARD 1987) says on one page that sonogram is good for cyst
detection.
Love's
DR. SUSAN LOVE'S BREAST BOOK (ADDISON WESLEY 1990) has one half page each on
sonogram and transillumination.
Hirshaut's
BREAST CANCER: THE COMPLETE GUIDE (BANTAM 1992) has one half page each on
sonogram and transillumination.
Many
private practice radiologists are currently routinely screening women with cystic
breasts or those under fifty with sonograms even though the AmericanCollege
of Radiology does not recognize this as a screening tool. However, there is no
other acceptable alternative choice for the patient or better diagnostic tool
for the physician other than the non specific MRI exam. Every finding (30%
specificity) must be biopsied to be verified.
